UW-spinoff PvP Biologics has announced a $35 million agreement with Takeda Pharmaceutical to advance its therapy for celiac disease. The therapy, an oral enzyme called KumaMax, is currently in pre-clinical development.
Celiac disease is an immune system disorder in which even small amounts of gluten can damage the digestive system and lead to significant health problems, including acute gastrointestinal distress and malnutrition. The disease affects more than two million Americans.
Currently, the only accepted treatment for celiac disease is a gluten-free diet. PvP Biologics, with the help of Takeda Pharmaceutical, hopes to change that. KumaMax, their uniquely engineered, recombinant enzyme, targets the specific parts of gluten that trigger the autoimmune response.
The enzyme was developed over the course of five years by Ingrid Swanson Pultz and David Baker at the University of Washington’s Institute for Protein Design. The two co-founded PvP Biologics, which officially launched late last year. Pultz now serves as the company’s chief scientific officer.
Over the last five years, CoMotion at the University of Washington has partnered with PvP Biologics to help advance the technology on an oral enzyme for the treatment of celiac disease towards clinical development and the FDA approval process. These efforts included two grants awarded from the CoMotion Innovation Fund, a Commercialization Fellowship provided to Dr. Pultz early in the project, funding for an economic impact report and outcome metrics for FDA filings, extensive mentoring by CoMotion Entrepreneurs-in Residence, execution of many confidentiality and material transfer agreements to protect the underlying UW-owned intellectual property, and the negotiation of an option and evaluation license, as well as the recently signed exclusive licensing agreements.